Prostatic Hyperplasia Clinical Trial
Official title:
Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be
associated with improved clinical outcomes for patients with enlarged prostates (EP) and
lower health care related costs.
The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and
length of therapy and the likelihood of acute urinary retention (AUR), prostate-related
surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or
prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and
Medicare population. The null hypothesis is that no differences will be observed in the
outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not.
The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer
period of time will experience significantly fewer adverse outcomes and significantly lower
treatment costs.
The data source for this analysis is the MarketScan database, which contains medical and
pharmacy claims for commercial health plan members and Medicare recipients. Medical and
pharmacy claims data are sourced directly from health plans and employers. The database
represents approximately 18 to 20 million individuals annually and nearly 22 million
Medicaid enrollees from multiple states. The database includes the Medicare-covered portion
of payment, the employer-paid portion, and any out-of-pocket expenses paid by the
beneficiary.
The study design is a retrospective cohort analysis. Each patient's index date was defined
as the date of the first fill for a 5ARI prescription.
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